Microbiologist

Responsibilities

• Implement laboratory test activities and ensure compliance with Good Laboratory Practice (GLP) and relevant procedures.
• Perform chemical and microbial testing (e.g., sterility, bioburden, and particulate tests) for materials, water, environment, and products.
• Provide microbiological support to production, including solutions for microbial control in cleanrooms and production areas.
• Manage the decontamination of returned implant devices and document the process.
• Manage laboratory reagents and consumables, ensuring proper preparation and storage.
• Analyze abnormal laboratory data and perform Corrective and Preventive Actions (CAPA).
• Prepare Verification and Validation (V&V) plans, protocols, and reports.
• Ensure all documentation complies with the quality system and Good Manufacturing Practice (GMP) standards.

Requirements

• Proven experience in microbial and chemical testing within a manufacturing environment.
• Strong knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
• Experience with CAPA (Corrective and Preventive Actions) processes.
• Experience in preparing V&V (Verification and Validation) documentation.
• Ability to follow strict regulatory and industry standards for medical device safety.

About the Company

Cochlear is the global market leader in implant hearing solutions. Our mission is to help people hear and be heard by providing innovative technology that restores a sense through engineering. We are an iconic Australian company dedicated to helping people with hearing loss lead full and active lives.